ISO9001_2015 Webinar Overview

DQS-ULManagementSystemsSolutions©
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FDIS ISO9001:2015 Overview
Welcome
Revisions & Impact

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Jawaid.Mansour@us.dqs-ul.com
Joe Mansour
ISO9001:2015 Program Manager
Lead Auditor
760-458-3879 (office/cell)

Today’s Presentation ISO9001:2015
1. Scope
2. Normative reference
3. Terms and definitions
4. Context of the organization
5. Leadership March 25, 2015
6. Planning
7. Support April 29, 2015
8. Operation
9. Performance evaluation May 26, 2015
10. Improvement
ISO 9001: Annex A-C – Clarifications, Quality Management Principles, QMS family of standards.
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… Final Webinar on July 29, 2015 .

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www.ul-dqsusa.com
http://ul-dqsusa.com
ISO9001:2015 Revision

Questions?
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ISO9001_2015_Questions@us.dqs-ul.com
Please send your questions to:
Next Webinar: As needed.

Questions From The Last Webinar
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Q40 How should we address the
exclusion of design process in our
organization
Clause 4.3 requires
justification for any instance
where a requirement of
ISO9001:2015 cannot be
applied... It may be defined in
any document, or any media.
(i.e. a process map).

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Q41 Is traceability back to a
specific gage number required for
product acceptance?
Section 8.3.5 does require the design and
development outputs to include or
reference monitoring and measuring
requirements, and acceptance criteria, but
not monitoring and measuring equipment.

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Q42 Where is the documnt N-1222 located?
on the ULDQS wbsite?
This document is not available on our website.
Please refer to question C3 on how it could be
accessed.

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Q44 Will
element-based
audits definitely not
meet the
requirements of the
standard?
YES!

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Q47 Will Risk Analysis need to be done to
processes such as Purchasing, Human
Resources, Training, etc. ?
Clause 4.4, item (f) requires that the risks and
opportunities be determined for all processes.
Clause 6.1 requires the risks to be addressed. Also,
actions taken to address risks and opportunities may
be proportional to the potential impact on the
conformity of the products and offered services. .

Questions?
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DIS to FDIS Changes
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FDIS is now available
IS (International Standard) is on track for release by
September 15, 2015
ISO
9001
2015

DIS to FDIS Changes
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ISO
9001
2015
Document of Compromise – 163 countries
- November 2014 - Galway, Ireland
- February 2015 - Vilnius, Lithuania
- 89% approval – 3200 comments received and
considered.

ISO9001:2015 ISO14001:2015
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No Major
Changes!

Key Changes
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• Removed
from Section
3 and moved
to ISO9000
Terms and
Definitions

Section 3 – Terms & Definitions
3.08 –
OBJECTIVE
Result to be
achieved.
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3.09 - RISK
Effect of
uncertainty on
an expected
result.
The effect can
be positive or
negative
consequence
- Risk is
characterized
by potential
events and
consequences.
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3.11 – DOCUMENTED
INFORMATION
Information (3.50) required to
be controlled and maintained
by an organization (3.01) and
the medium on which it is
contained.
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Key Changes
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Quality Management System
Principles removed from Appendix
B and moved to ISO9000

Key Changes
20
New Figure added in
Introduction
Single figure that depicts the concept of
”Process Approach”
Text has been slightly revised
as well.

Key Changes
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RISKS
OPPORTUNITIES

Key Changes
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Use of “Continual
Improvement”
Clarified

Key Changes
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KEY
CHANGES
Processes
Customer
Focus
Planning
Resource
Work
Environment
Organizational
Knowledge

Key Changes
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• 7.3 - Awareness
• 7.4 - Communication
• 7.5.3.2 - Unintended Change in Documented
Information
• 8.2 - Product and Service - Changes
• 8.3 Design - Retention of records; Review, Verification,
Validation

Key Changes
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8.2.1 – Customer Communication
8.2.2 – Requirements for Products/Services
8.2.3 – Review of Requirements
8.2 – DETERMINATION OF REQUIREMENTS FOR
PRODUCTS AND SERVICES

Key Changes
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8.4 – Externally Provided
Processes - clarification
8.6, 8.6, 8.7 - Outputs
8.5.1 – The implementation of
action to prevent human error

Key Changes – April Webinar
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Tester
Reject

Key Changes – April Webinar
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Tester
Reject

Key Changes
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8.5 – Minor changes in
Production and Service
Provision
8.7 – Removal of term
“Corrective” related to
Nonconformity Control

Key Changes
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9.1.3 Analysis and Evaluation
9.1.1 - Customer Satisfaction
Minor Changes in Sections 9
and 10

Key Changes
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9.2 – Reference to consider Quality
Objectives deleted
9.3 – Information for Management Review
10.1 – Improvement - General
10.2 – Nonconformity and Corrective
Action
10.3 – “Outputs” replaced by “Results”

Key Changes
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9.2 – Reference to consider Quality
Objectives deleted
9.3 – Information for Management Review
10.1 – Improvement - General
10.2 – Nonconformity and Corrective
Action
10.3 – “Outputs” replaced by “Results”

Key Changes
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Overall –
Minimal Impact
on Intent

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Transition Process
ISO9001:2015 &
ISO14001:2015

Transition Plan
UL DQS
TRANSITION
PLAN
ISO9001:2008 To
ISO9001:2015
ISO14001:2004 To
ISO14001:2015
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Transition Plan
September 2015:
Start of 3 years transition period to September 2018
September 2015:
Published
International Standard

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Part Of Its Scheduled Recertification Audit;
with additional days, if needed
In a Planned Manner During Continuous
Assessment/Added Days
Through a Special Transition Audit.
Transition Plan
An Organization may be upgraded to
ISO9001:2015 or ISO14001:2015

The most cost-effective way is to upgrade
during the normally scheduled Recertification
Audit.
Upgrade audits done as part of the
Continuous Assessment and Special audits
will be carried out for the same number of
days as a recertification audit (including Stage
1 and Stage 2)
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2008 to 2015 Transition

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• Stage 1
• Stage 2
ALL
UPGRADE
AUDITS

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Stage 1 Agenda Items
Identification of Interested Parties and their
requirements.
Identification of Gaps and actions needed
Identification of Risks and Opportunities
Identification of Processes
Context of the Organization and
Leadership Requirements

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Stage 1 Agenda Items
Review of one round of process-based
Internal Audits to ISO9001:2015
At least one management review after
the completion of the audits.
Ensure Understanding of the
Requirements
Deployment of Process-based
Management System
Stage 1 to be done about eight weeks
prior to Stage 2.

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Is a complete MR and IA expected
before certification/upgrade
against ISO :2015 For Stage 1?
Yes; with Risk.

2015 Standards Transition
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Please let your
Customer Service
Professional know
well in advance of
your audit when
you are ready to
upgrade.
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ISO9001:2015 Transition
Process and Requirements
Availability of Gap
Assessments
ISO9001:2015 Available Services
Services

Quality System Checklist
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Quality System Checklist
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Informational Sessions
ISO9001:2015 &
ISO14001:2015

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4 Hour Executive
Review
8 Hour Overview
2 day Internal
Auditing
2.5 day Integrated
Audit 9K/4K
Informational Offerings

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8:00 am Start, Welcome
8:30 Reasons for the revision of the Standard &
their benefits
9:30 FAQ document
10:15 Transition Policy, Stage 1 & 2
10:45 UL DQS Readiness Reviews
11:30 Q&A – additional topics, as needed
12:00 pm End of Event
Executive Review – 4 Hours
ISO9001:2015 or ISO14001:2015

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9:00 Reasons for the revision of ISO 9001 & their
benefits
9:15 Roadmap to revision
9:30 Review of Section 0-4
10:30 Break
10:45 Review of Sections 5-7
12:00 Lunch
12:30 pm Review of Sections 8-10
1:30 FAQ document
2:30 Break
2:45 Transition Policy, Stage 1 & 2
3:30 UL DQS Readiness Reviews
4:00 Q&A – additional topics, as needed
5:00 pm End of event
Changes to the Standard –8 Hours
ISO9001:2015 or ISO14001:2015

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Completion of an on line study module designed to ensure
better understanding of the requirements.
- Takes about 8 hours to complete.
- Successful completion needed before the two day in-person
presentation.
Auditing to ISO9001:2008 or ISO14001:2015

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Reasons for the revision & their benefits
9:00 am Review of Sections 0-4
10:45 Break
12:00 Lunch
12.30 Workshop “Interested parties and identification
of their expectations”
1:30 Review of workshop results
2:30 Break
2:45 Workshop on “Risk-Based Thinking”
3:30 Introducing tools on how to identify risks
4:15 Presentation of Workshop result
5:00 pm End of Day.
Day 1

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8:30 am Start, Mind Map – Lessons Learned
9:30 Process-based Internal Audits
10:30 Break
10:45 Workshop: Preparing an internal audit program
12:00 Lunch
12:30 pm Presentation of results
1:30 Leadership and commitment (presentation)
2:30 Role Play : Interviewing the General Manager
3:30 Documented Information (presentation)
4:00 UL DQS readiness reviews and Transition
Process
4:30 Q&A Session
5:00 pm End of event
Day 2

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Integrated Audits to ISO 9001:2015 and
ISO 14001:2015 – how to conduct
internal audits for organizations with
integrated ISO 9001 and ISO 14001
systems
Auditing to ISO9001:2008 and ISO14001:2015
2.5 Days

Please let your
Customer Service
Representative or
Regional Sales
Representative
know should you
be interested in
these services.
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Q1 What is the current
difference between element
approach and process approach?
Explanation of Process Approach was
included in slides 30-49. ISO9001:2015
requires all Processes (value-added
activities of the organization) be
identified and managed as a process.
Element-based standards just outline
the requirements.

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With respect to the context of the organization, the
Quality Management System requirements are to be
considered in meeting customer requirements.
Furthermore, those requirements will have to be
integrated into the Business Management System of the
organization.
Q31 Is the Context Of The Organization
directed only towards the Quality
Management System or the Entire Business
Management System

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Q34 Can the
processes be
grouped? with
generic inputs,
outputs, measures,
responsibilities,
etc. or does each
specific process
need to have each
item listed in clause
4.4.
Items a-h of section
4.4 has to be
addressed for all
processes.

Questions?
Contact:
Joe Mansour
ISO9001:2015 Program Manager
60

ISO9001_2015 Webinar Overview

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